NES + Testosterone Gel
NES/T
- User: Male
- Hormonal: Hormonal
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Delivery type:
- Transdermal
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Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): Population Council, LA Biomedical Research Institute, University of Washington, Health Decisions, NICHD, Contraline
Details
- API: Nestorone, Testosterone
- Target: Progesterone Receptor, Androgen Receptor
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Mechanism of Action:
- Reduced Sperm Production
- Inactive Materials: Hydroalcoholic Gel
- Regimen: 1 Application/Day
- MPT: Not Potential MPT
- Promising Attributes: NES/T, one of the furthest-advancing contraceptive products for male users currently under development, has reliable return to fertility post-use and aligns with user research that suggests interest in transdermal, user controlled delivery systems.
Product Status
Active Clinical Research
History
2005: Phase I study initiated by Population Council to evaluate whether nestorone gel in combination with testosterone gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone.
2009: Phase I study initiated to evaluate safety and sperm + gonadotropin supression from a combined NES/T gel
2015: Phase I randomized, double-blinded trial initiated to evaluate PK and gonadotropin supression of NES/T gel
2017: Phase I open-label trial evaluating secondary exposure of female non-users to NES/T applied by male users
2018: Phase IIb open-label multi-center trial initiated to evaluate contraceptive efficacy, safety, and infertility biomarkers.
2024: Phase IIb trial concludes, enrolling 420 couples recruited through the Contraceptive Clinical Trials Network.
2025: Contraline announces intention to exercise their exclusive licensing option for NES/T, supporting the method through Phase III clinical evaluation and commercialization.
2026: Contraline announces $92.5M series B financing led by BVF Partners and RA Capital Management to advance NES/T through Phase III trials. Contraline shares intention to initiate Phase III trial in 2027.